Smoking, Alcoholism
Conditions
Keywords
Smoking, Alcoholism
Brief summary
The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.
Interventions
BEHAVIORALCognitive Behavior Therapy for alcohol and smoking cessation
Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.
Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy.
DRUGPlacebo gum
Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks.
DRUGNicotine gum - Nicorette®
Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females at least 18 years old. * English speaking. * Meets criteria for alcohol dependence or alcohol abuse. * Must complete an alcohol detoxification program prior to entering the study. * Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking. * Have a current desire to stop smoking and stop drinking. * Willing to complete followup assessments up to 12 months after treatment. * Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use. * One person per household.
Exclusion criteria
* Allergy to nicotine patch or nicotine gum. * Weigh less than 100 pounds. * Use other nicotine products, such as cigars, pipes or smokeless tobacco. * Severe skin disorder. * Active peptic ulcer. * Active joint disease. * Heart attack within 3 months prior to entering the study. * Pregnant or breastfeeding female who are not on birth control. * Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion. * Poor vision or hearing that would interfere with using a cell phone. * Lack of transportation to the treatment site or live at least one hour from the treatment site. * Homeless.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Month Smoking Abstinence | 6 months after smoking quit date | Percentage of participants with prolonged carbon monoxide verified smoking abstinence |
| 12 Month Smoking Abstinence | 12 months after smoking quit date | Percentage of participants with prolonged carbon monoxide verified smoking abstinence |
Countries
United States
Participant flow
Recruitment details
96 men and women were randomized to treatment at the Newington and West Haven campuses of the Veterans Affairs (VA) Connecticut Healthcare System.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Patch Plus Active Gum | 45 |
| Nicotine Patch Plus Placebo Gum | 51 |
| Total | 96 |
Baseline characteristics
| Characteristic | Nicotine Patch Plus Active Gum | Nicotine Patch Plus Placebo Gum | Total |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 10.2 | 44.8 years STANDARD_DEVIATION 10.1 | 44.9 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 45 participants | 51 participants | 96 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 32 Participants | 37 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 45 | 7 / 51 |
| serious Total, serious adverse events | 0 / 45 | 0 / 51 |
Outcome results
Primary
12 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Time frame: 12 months after smoking quit date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Patch Plus Active Gum | 12 Month Smoking Abstinence | 13 percentage of participants abstinent |
| Nicotine Patch Plus Placebo Gum | 12 Month Smoking Abstinence | 0 percentage of participants abstinent |
p-value: <0.01Chi-squared
Primary
6 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Time frame: 6 months after smoking quit date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Patch Plus Active Gum | 6 Month Smoking Abstinence | 20 percentage of participants abstinent |
| Nicotine Patch Plus Placebo Gum | 6 Month Smoking Abstinence | 12 percentage of participants abstinent |